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NCT01215864 · ClinicalTrials.gov registry record · Phase 1
Study of Intravenous TCD-717 in Patients With Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Traslational Cancer Drugs Pharma, SL.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 2
- Study locations
NCT01215864: Completed Phase 1 study of Advanced Solid Tumors, sponsored by Traslational Cancer Drugs Pharma, SL.
NCT01215864 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Traslational Cancer Drugs Pharma, SL. The registered enrollment target is 28 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01215864, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Traslational Cancer Drugs Pharma, SL.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of this study are to evaluate the safety of the drug and to determine the maximum tolerated dose and appropriate dose for phase II studies. Secondary objectives are to measure the efficacy of TCD-717; and in a substudy to be conducted in the MTD confirmation cohort only, to evaluate the potential correlation between the levels of tumor choline and tumor response to the choline kinase alpha inhibitor, TCD-717, using magnetic resonance spectroscopy. Pharmacokinetics analysis will be performed on patients enrolled in the maximum tolerated dose confirmation cohort.
Primary Outcome
Patients will be monitored throughout the study for adverse events and dose limting toxicities.
Conditions Studied
Interventions
- DRUG TCD-717
Study Locations (2)
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01215864 record still lists
NCT01215864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which TCD-717 is the first listed.
NCT01215864 reports a single indexed study location in Maryland, Michigan.
Frequently Asked Questions
What is clinical trial NCT01215864 about?
NCT01215864 is a clinical study titled "Study of Intravenous TCD-717 in Patients With Advanced Solid Tumors". This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of this study are to evaluate the safety of the drug and to determine the maximum tolerated dose and appropriate do...
What is the current status of trial NCT01215864?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-01. Estimated completion is 2014-02.
What conditions does trial NCT01215864 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT01215864?
The interventions under investigation include: TCD-717 (DRUG).
Who is sponsoring clinical trial NCT01215864?
This trial is sponsored by Traslational Cancer Drugs Pharma, SL, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01215864 being conducted?
This trial has 2 study locations across Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01215864's enrollment target sits among peer trials
28 117th of 144 higher than 28 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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